20 days old

Sr Supplier Quality Engineering Manager

Medtronic
Northridge, CA 91325
Sr Supplier Quality Engineering Manager

Location:

Northridge, California, United States

Requisition #:

19000L90

Post Date:

Oct 31, 2019


**Careers that Change Lives**


The Sr Supplier QualityEngineering Manager will partner with Medtronics suppliers (internal and external), and their respective suppliers, processes, and systems to prevent defects, and allow us to provide our customers with the highest quality and most reliable products.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.


The Sr Supplier QualityEngineering Manager will manage all aspects of tier one suppliers, and where necessary sub-tier suppliers, supplier quality activities for assigned suppliers/commodities; drive quality and process improvement at assigned suppliers/commodities. Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, and general supplier development. Review and approve inspection sampling plans or drive source inspections for select parts. Assume special assignments to drive internal or supplier processes or address critical commodity and/or supplier concerns.


**DIABETES**


Transforming diabetes care together, for greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.


Visit medtronicdiabetes.com at http://www.medtronicdiabetes.com/ to see an overview of the products in our Diabetes product portfolio.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Selects, develops and manages personnel to ensure the efficient operation of the functionas well as capability and areas of improvement.

+ Plans, directs and implements all aspects of the company'sSupplier Quality requirements in thedesign and development of new medical device products or software systems.

+ May develop, evaluate, implement and maintainsupplierquality assurance and control systems and standards pertaining to materials, techniques, orsuppliersproducts, parts, and components.

+ Oversees the investigation and evaluation of existing technologieswith the NPD teams.

+ Guides the conceptualization of new methodologies, materials, machines, processes or productswithin the Supplier Quality realm in partnership with the NPD teams.

+ Directs the development of new concepts from initial design to market releasein conjunction with the NPD teams.

+ Manages feasibility studies of theprocesses required to make and qualify partsto determine if capable of functioning as intended.

+ Monitors documentation maintenance throughout all phasesof assigned necessary deliverables.

+ Ensures that suppliers deliver quality parts, materials, and services.

+ Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

+ Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

+ Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

+ Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

+ Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

+ Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecyclefornewly qualified parts from NPDthrough the use of PPAP/APQP, as well as utilizing MSA, GRR, TMV, CSV, process characterization and measurement development, and all protocol oversight with suppliers. Alsoimplementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirementswill be required and implemented as necessary.

+ Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

+ Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.


**Must Have: Minimum Requirements**


Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with5+ years of leadership experience


OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with5+ years of leadership experience


**Nice to Have**


+ Experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry

+ Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV)

+ Prior experience with electrical, chemical, plastics, mechanical, and/or electro-mechanical commodities

+ Advanced degree (MS and/or MBA), Masters degree in Engineering or Scientific field with an emphasis in Engineering, Materials, Quality Assurance, or Quality Systems

+ ISO 13485 Lead Auditor Certification

+ Experience with polymers, plastics and injection molding is highly desirable

+ Knowledge with PPAP/high volume process and part validation techniques

+ Knowledge of the Medical Device regulations (21 CFR 820 and ISO 13485)

+ ASQ certified quality engineer (CQE) and/or black belt certification

+ Ability to work with minor guidance and under pressure

+ Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and industry standards where applicable

+ Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes

+ Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies. Must be a team player.


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)


Ability to travel internationally 25-50%
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2019-10-31 Expires: 2019-12-12

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Sr Supplier Quality Engineering Manager

Medtronic
Northridge, CA 91325

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